VIVUS, Inc., a biopharmaceutical company, and Auxilium Pharmaceuticals, Inc., a fully integrated specialty biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Stendra (avanafil). Stendra is now the only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity.
Stendra is a prescription medication in a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors approved for the treatment of ED in men 18 years or older. Stendra is available in multiple dosage strengths (50, 100 and 200 mg tablets) and may be taken with or without food and moderate alcohol consumption (up to three drinks). In clinical studies, when compared to placebo, Stendra helped more men achieve an erection in as early as approximately 15 minutes that lasted long enough to successfully complete sexual intercourse.
"ED patients in my practice are looking for a safe and effective treatment option that also works fast," said Wayne JG Hellstrom, M.D., FACS, Professor of Urology at Tulane University School of Medicine in New Orleans and primary investigator for the clinical trial. "In my opinion, Stendra can be an appropriate and important treatment option because the clinical trial demonstrated that it provides a rapid onset of action in many men in as early as approximately 15 minutes."
"Stendra is the first FDA-approved ED drug in nearly a decade and offers men and their partners an exciting new option," said Adrian Adams, chief executive officer and president of Auxilium Pharmaceuticals. "We believe this label expansion helps position Stendra as an exciting 'on demand' ED treatment and assists with the very important aspect of spontaneity for men and their partners in real world use. We believe this provides a meaningful benefit for men with ED and further underscores Auxilium's commitment to being an innovative leader in men's healthcare."
"We are pleased with the approval of the sNDA for Stendra," said Seth H. Z. Fischer, chief executive officer of VIVUS. "The positive clinical study results, now part of the label, demonstrate Stendra's rapid onset of action. We believe this is good news for men suffering from ED and for the healthcare providers who treat them."
ED is the inability to attain or maintain a penile erection for sufficient sexual performance. Men may experience ED differently. Many men with ED experience one or more of the following: trouble achieving an erection; difficulty achieving an erection firm enough for penetration; or erections not lasting long enough to have successful intercourse. In the Massachusetts Male Aging Study, it is estimated that 52% of men over 40 years of age experience some degree of ED. In addition to advanced age, recognized risk factors for erectile dysfunction include cardiovascular disease (hypertension, atherosclerosis, and hyperlipidemia), diabetes, depression, alcohol use, smoking, pelvic/perineal surgery or trauma, neurologic disease, obesity, pelvic radiation, and Peyronie's disease.
The sNDA filed by VIVUS was based on results from Study TA-501 entitled, "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction." The study was designed to assess the efficacy of two dosage strengths of Stendra as early as approximately 15 minutes after dosing. In this 440-patient study conducted at 30 sites in the US, patients treated with Stendra had a significantly higher proportion of attempts that enabled an erection sufficient for successful sexual intercourse as early as approximately 15 minutes following administration compared to placebo. The previously approved prescribing information recommended administration approximately 30 minutes before sexual activity.
Stendra (avanafil) is the only FDA-approved ED medication indicated to be taken as early as approximately 15 minutes before sexual activity. Stendra helped more men achieve an erection in approximately 15 minutes that lasted long enough to successfully complete sexual intercourse when compared to placebo. Stendra should not be taken more than once per day and may be taken with or without food and with moderate alcohol consumption.
Auxilium Pharmaceuticals, Inc. has exclusive marketing rights to Stendra in the US and Canada.
Spedra, the trade name for avanafil in the European Union (EU), is approved by the European Medicines Agency (EMA) for the treatment of ED in the EU. VIVUS has granted an exclusive license to the Menarini Group through its subsidiary Berlin-Chemie AG to commercialize and promote Spedra for the treatment of ED in over 40 European countries plus Australia and New Zealand.
VIVUS has granted an exclusive license to Sanofi to commercialize avanafil in Africa, the Middle East, Turkey, and the Commonwealth of Independent States (CIS) including Russia.
Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian-Pacific Rim countries. VIVUS is in discussions with other parties for the commercialization rights to its remaining territories.
Auxilium Pharmaceuticals, Inc. is a fully integrated specialty biopharmaceutical company with a focus on developing and commercializing innovative products for specialist audiences.